FDA Approves Pfizer Abrysvo RSV Vaccine for Older Adults

The FDA has approved Pfizer’s Abrysvo respiratory syncytial virus (RSV) vaccine for the prevention of lower respiratory tract disease in individuals 60 years and older.

The bivalent vaccine is composed of two proteins to protect against both RSV A and B strains and was approved on the basis of data from a phase 3 trial that showed the vaccine was 85 percent effective in preventing an infection with at least three symptoms.

The company also says it is initiating multiple trials evaluating the vaccine in healthy children ages 2-5, children ages 5-18 with underlying medical conditions, adults ages 18-60 at high-risk due to underlying medical conditions and adults ages 18 and older who are immunocompromised and at high-risk for RSV.

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